Bevacizumab for the Treatment of Retinopathy of Prematurity

Genie M. Bang, MD; Sophie J. Bakri, MD


January 23, 2012

Efficacy of Intravitreal Bevacizumab for Stage 3+ Retinopathy of Prematurity

Mintz-Hittner HA, Kennedy KA, Chuang AZ; BEAT-ROP Cooperative Group
N Engl J Med. 2011;364:603-615

Study Summary and Viewpoint

The Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity (BEAT-ROP) study was a prospective, randomized, stratified, controlled, multicenter trial that compared intravitreal bevacizumab monotherapy with conventional laser therapy in cases of stage 3+ retinopathy of prematurity (ROP) with zone I or II posterior disease.

The current standard of care for ROP is diode laser therapy, following guidelines set forth by the findings of the Early Treatment for Retinopathy of Prematurity study in 2003. If regression of ROP does not occur after multiple applications of conventional laser therapy, vitrectomy is required.

The BEAT-ROP study showed a significantly higher rate of recurrence in zone I disease with conventional laser therapy compared with intravitreal bevacizumab monotherapy (42% [14 of 33 infants] vs 6% [2 of 31 infants], P = .003). However, the rate of recurrence in zone II posterior disease did not differ significantly between the 2 groups (12% [5 of 40 infants] vs 5% [2 of 39 infants], P = .27).

The study observed a difference in the timeline of recurrence between the 2 groups (16.0 ± 4.6 weeks for intravitreal bevacizumab vs 6.2 ± 5.7 weeks for conventional laser therapy). The authors cautioned clinicians that careful follow-up is required for infants treated with bevacizumab monotherapy and that safety in neonates is an important issue for intravitreal bevacizumab. This study did not observe systemic or local toxicity and the investigators noted that the size of the BEAT-ROP study (150 infants) was not large enough to assess safety.

An interesting aspect of this study is that conventional laser therapy resulted in permanent destruction of vessels and areas of treated retina. However, eyes treated with intravitreal bevacizumab had continued vessel growth into the peripheral retina.

Intravitreal bevacizumab monotherapy had a lower recurrence rate in zone I disease compared with conventional laser therapy. Further studies are needed to determine the dose and medical safety profile for infant patients, as well as recommendations for the frequency and duration of follow-up after treatment.